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Declining GMP (good manufacturing practice) inspections a matter of concern for FDA

This article was originally published in Clinica

Executive Summary

The FDA's declining inspection rate threatens to undermine the agency's global reputation, the head of FDA's device centre warned last week. "What does the FDA export certificate (ie approved by the FDA) mean when inspections are dwindling so greatly," said David Feigal, director of FDA's Center for Devices and Radiological Health (CDRH). "It's one of the issues that's beginning to concern me," he said.





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